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Doctors want US FDA to halt cold medicines for kids
October 2, 2008 / 5:33 PM / 9 years ago

Doctors want US FDA to halt cold medicines for kids

BELTSVILLE, Md., Oct 2 (Reuters) - Over-the-counter cough and cold medicines should not be sold for young children because they are unproven and can be dangerous, doctors and consumer advocates said on Thursday, despite objections from industry representatives.

Experts urged U.S. Food and Drug Administration officials to ban sales of the products, which include versions of Wyeth’s WYE.N Dimetapp and Procter & Gamble Co’s (PG.N) NyQuil, for children ages 2 to 6.

Other products also include Novartis AG’s NOVN.VX(NVS.N) Triaminic and Johnson & Johnson’s (JNJ.N) Tylenol and PediaCare, among others.

“Cough and cold medications ... have not been proven to be effective and they have clear risks. It is time for them to be reevaluated,” Dr. Wayne Snodgrass of the University of Texas Medical Branch, said at an FDA meeting to discuss whether the nonprescription remedies should be sold for children.

Such products have been sold for decades and aim to combat runny noses, coughs, congestion and other symptoms. But they can potentially increase the risk of stroke, seizures and other complications, often because of dosing errors.

They also have never been proven to work, the doctors said.

In January, the FDA recommended against their use in children up to 2 years old and products aimed at that age group have been recalled. It is still deciding whether to take action for children of other ages.

An FDA panel of outside experts last year said nonprescription cough and cold medicines should not be given to children under age 6.

Unlike some children’s medicines, these drugs were allowed on the market under special rules for over-the-counter products that do not required data showing safety and efficacy. Instead, data were extrapolated from adults.

Industry representatives rejected the concerns, saying cold medicines are safe for children over 2 years old when used as directed.

Without them, parents may turn to inappropriate adult products or simply try alternative treatments that could be risky, Linda Suydam, head of the Consumer Healthcare Products Association (CHPA).

“We know from real world use ... that serious adverse events are rare,” said Suydam, whose group represents over- the-counter drugmakers.

Companies are launching several studies to look at individual ingredients, she added. They are also trying to educate parents and improve packaging to help parents properly use them.

Roughly 95 million packages are sold in the United States each year, according to CHPA, which did not have sales figures for the industry.

There is no cure for the common cold, but parents often feel pressured to use a product to help their sick child feel better, some physicians said. And while the American Academy of Pediatricians now rejects use of such remedies, some doctors still suggest them.

But Dr. Janet Serwint, a professor at Johns Hopkins University, said attitudes among parents, newer doctors and medical students are changing.

“I think parents really don’t want to give their children medication,” she told the FDA.

The FDA had said it planned to issue an opinion on children ages 2 to 6 earlier this year, but in August asked for more information and announced a public meeting.

The agency could change its rules to further restrict use of the products in children, a process that could take years, or it could require the products to go through a new approval process requiring clinical trials. Officials also could issue an advisory with recommendations for parents.

But doctors and advocates said the agency already knows the drugs have never been proven and has had years to act.

“It’s a problem of lack of will,” Diana Zuckerman, president of the National Research Center for Women & Families, said in prepared comments for the agency. (Reporting by Susan Heavey; Editing by Andre Grenon)

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